1. Field of the Invention
This invention relates to a kit for assembly of a container which is suited for the handling and shipping of explanted orthopedic implants and/or tissue samples or other potentially biohazardous materials.
2. Description of the Related Art
When orthopedic implants are removed from patients ("explanted orthopedic devices"), they must frequently be shipped to the manufacturer, often with an accompanying tissue sample, for examination and/or analysis for a variety of reasons, including regulatory responses. These materials are potentially biohazardous to those individuals handling the items during retrieval, shipping and examination.
In the past, medical personnel responsible for returning explanted orthopedic devices had to package, label, and ship the items by using packaging and labels chosen at their own discretion, which were often less than adequate. Many packages were packed and labeled in a manner lacking protection for those handling the package from potentially contaminated material.
Regulations have been promulgated by various agencies and associations relating to the shipping, handling, and mailing of such biomedical materials. The Postal Service proposed a rule for inclusion in 39 Code of Federal Regulations (CFR) Part 111, Mailability of Sharps and Other Medical Devices (Federal Register, Vol. 57, No. 53, Wed., Mar. 18, 1992), which states in part:
. . . used medical devices which do not have or contain a projecting sharp [sic] must be packaged in a securely sealed, leak resistant primary container. The primary container must be enclosed in a shipping container that is constructed of 275-pound grade corrugated fiberboard or similar material of equivalent strength. The total volume of liquid in the primary and shipping container must not exceed 50 ml., unless the devices are mailed in a formalin solution or its equivalent. There must be sufficient absorbent material between the primary and shipping container to absorb three times the total liquid allowed within the primary container, except when the device is being shipped in a formalin solution.
Several patents describe methods and devices for preserving and transporting biological materials or prosthetic devices. U.S. Pat. No. 3,255,871 to Butler is directed to the use of a translucent plastic bag in which a formaldehyde solution is formed in situ for preserving and transporting biological material. For long distance transportation, the bag is placed in a suitable shipping carton. However, this product does not afford the protection provided by multiple liquid sealed barriers so that any leakage from this primary container could potentially infect handlers thereof.
U.S. Pat. No. 4,011,947 to Sawyer describes a packaged prosthetic device and a packaging technique designed so that a prosthetic device will arrive at its ultimate position for installation in a sterile and clean condition. However, this patent does not describe a method or device for handling and shipping a potentially biohazardous material, partially those shipped in a liquid preservative.
U.S. Pat. No. 4,530,816 to Douglas-Hamilton describes a method and device for cooling, preserving and transporting biological material such as equine semen specimens and equine embryos, with the primary concern being to maintain a specified temperature range for increased viability.
Thus, there is a need to provide a kit so that a shipping container can be assembled for a variety of explanted orthopedic devices and/or tissue samples and other biomedical materials, such that these items can be handled and shipped in a safe and non-degenerative manner. This need is particularly apparent in view of the current AIDS epidemic and the known transmittal of the AIDS virus through bodily fluids.